December 14, 2011 - See Notice NOT-OD-12-022. Ruth L. Kirschstein National Research Service Awards (NRSA) and Other Fellowship Applications: New Policy on Post-Submission Information on Sponsor’s Research Funding.

Effective Date
Applications submitted to the NIH for the September 25, 2010 due date and thereafter

Purpose
This Notice serves to announce that NIH soon will change its Amended NIH Policy on Submission of Late Grant Application Materials Prior to Initial Peer Review (NOT-OD-10-070), and will rescind the NIH Best Practice Guidelines for Accepting Additional Grant Application Materials (Revised 03/19/2010); these changes will become effective for applications submitted for the September 25, 2010 receipt date and thereafter. Note that this policy does not modify the existing Just-In-Time requirements or any other requests for additional information after the initial peer review.

This early notification is intended to provide applicants sufficient time to prepare for this transition. The new policy is intended to expedite timely peer review, reduce burden on NIH extramural staff and peer reviewers, and provide a uniform amount of materials for each grant application going to review.

Note: Post-submission of application materials is not required. Adding materials to reviewer workload may be counterproductive, so applicants should consider carefully the need to send post-submission materials.

Policy
The earlier policy (NOT-OD-10-070) allowed 1, 2, or 3 pages of post-submission materials, based on the page limits for the Research Strategy section of the application. However, for the majority of applications submitted for the September 25, 2010 receipt date and thereafter, the new policy will only allow grant application materials to be accepted after submission of the application but before the initial peer review if they result from unforeseen administrative issues. Exceptions to this policy are indicated below.

The deadline for receipt of post-submission materials is one month (30 calendar days) prior to the peer review meeting. Post-submission materials will not be accepted if fewer than thirty calendar days remain before the peer review meeting. Acceptable post-submission materials under the new policy will include:

Revised budget page(s) (e.g., change in budget request due to new funding or institutional acquisition)

Biographical sketches (e.g., change in senior/key personnel due to the loss of an investigator)

Letters of support or collaboration resulting from a change in senior/key personnel due to the loss of an investigator

Adjustments resulting from change of institution (e.g., PI moved to another university)

News of an article accepted for publication

Unacceptable post-submission materials [for all applications but those under Exceptions below] will include:

Updated Specific Aims or Research Strategy pages

Late-breaking research findings

Supplemental pages - information not contained in the existing application

New letters of support or collaboration that do not result from a change in senior/key personnel due to the loss of an investigator

Exceptions to the new policy will include:

Applications submitted in response to Requests for Applications (RFAs) that have only one due date. Post-submission materials for these applications will be accepted as outlined under the former policy (NOT-OD-10-070).

Applications for training grants. Additional guidance for these applications will be issued soon.

Certain NIH Funding Opportunity Announcements (FOAs) may allow certain other types of post-submission materials to facilitate the goals of the program. Such stipulations must be explained in the FOA in the NIH Guide for Grants and Contracts.

Page limits for post-submission materials under the new policy:

All post-submission materials must conform to NIH policy on font size, margins, and paper size as referenced in Part I.2.6 of the applicable application instructions.

NIH additional form pages such as budget, biographical sketches, and other required forms must follow NIH standards for required NIH form pages.

If post-submission material is not required on a form page, each explanation or letter is limited to one page (see Acceptable Late Materials above).

If the application has subprojects or cores, each subproject or core is allowed explanations or letters (see Acceptable Late Materials above), but each explanation or letter is limited to one page.

Authorized Organizational Representative (AOR) concurrence:
The requirement for concurrence from the Authorized Organizational Representative (AOR) of the applicant organization will continue under the new policy. Although the content of post-submission materials may originate from the PD/PI, Contact PD/PI for multiple PD/PI applications, or organizational officials, the AOR must send the materials directly to the SRO, or must send his/her concurrence to the PD/PI who will forward the materials and concurrence to the SRO. A communication from the PD/PI only or with a “cc” to the AOR will not be accepted.